BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN IC INFUSION CATHETER

    MDR report key: 6082614 · Received November 7, 2016

    Report

    Report Number
    3005831739-2016-00004
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    September 27, 2016
    Report Date
    November 3, 2016
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    K071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    - THE CLARIVEIN DEVICE WAS NOT AVAILABLE FOR INVESTIGATION; AND NO LOT NUMBER WAS PROVIDED IN THE COMPLAINT REPORT; THEREFORE, NO LOT HISTORY OR COMPLAINT LOG REVIEW COULD BE PERFORMED. - A PERIPHERAL VASCULAR (VENOUS) INFUSION PROCEDURE UTILIZING CLARIVEIN TO DELIVER LIQUID STS SCLEROSANT WAS SUCCESSFULLY PERFORMED ON THE GSV RIGHT LEG ON (B)(6) 2016. - POST CLARIVEIN PROCEDURE VARITHENA (POLIDOCANOL FOAM SCLEROSANT) INTERVENTIONAL PROCEDURES WERE PERFORMED ON THE GSV RIGHT LEG ON (B)(6) 2016. - FOLLOW-UP ULTRASOUNDS WERE PERFORMED ON (B)(6) 2016. - TREATING PHYSICIAN'S EVALUATION OF THE (B)(6) 2016 ULTRASOUND IDENTIFIED AN AV FISTULA; PHYSICIAN REPORTED THAT NO INTERVENTION WAS RECOMMENDED, WILL KEEP WATCH. - THE REPORT OF AN AVF CAME MORE THAN 4 MONTHS POST THE CLARIVEIN INFUSION PROCEDURE; THERE WERE NO ISSUES CITED WITH THE PERFORMANCE OF THE CLARIVEIN DEVICE OR WITH THE PROCEDURE. - THIS IS THE FIRST AND ONLY AV FISTULA INCIDENT REPORTED TO VI POST ANY CLARIVEIN INFUSION PROCEDURE - THERE ARE RARE CASES OF AVFS REPORTED IN THE MEDICAL LITERATURE AFTER THERMAL ABLATION PROCEDURES OF SAPHENOUS VENOUS USING RF AND LASER - ABOUT 25 IN THERMAL ABLATION HISTORY, DETECTED WITH DUS IN FOLLOW-UPS AS LONG AS 2 YEARS POST PROCEDURE. - THERE IS NO EVIDENCE OF DIRECT CONNECTION BETWEEN THE CLARIVEIN DEVICE AND THE DEVELOPMENT OF THE AVF; HOWEVER VI IS CONSERVATIVELY NOTIFYING THE FDA OF THIS EVENT OUT OF AN ABUNDANCE OF CAUTION. DEVICE NOT MADE AVAILABLE BY PHYSICIAN.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED A MALE PATIENT WHO PRESENTED WITH AN AV FISTULA (AVF) ON (B)(6) 2016. THERE WERE NO SYMPTOMS, NO INTERVENTION. THE 1ST TIME IT WAS OBSERVED WAS DURING A ROUTINE EXAM. DR. (B)(6) DID A FOLLOW ON EXAM TO VERIFY HIS CONCERN AND HE ALONG WITH ANOTHER (B)(6) AREA DR.(DR. (B)(6)) CAME TO THE CONCLUSION AN AVF WAS PRESENT. THE 1ST FOLLOW-UPS WERE POST VARITHENA. THIS PATIENT HAD AN INFUSION PROCEDURE PERFORMED MORE THAN 4 MONTH EARLIER ON (B)(6) 2016, DURING WHICH THE CLARIVEIN WAS USED TO DELIVER STS TO THE RIGHT GSV & AASV. THERE WERE NO ISSUES CITED WITH USE OF THE CLARIVEIN DEVICE OR THE INFUSION PROCEDURE PERFORMED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732175 CLARIVEIN IC INFUSION CATHETER CLARIVEIN IC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR